US-based medical devices firm Imricor Medical Systems has obtained CE mark approval for its Vision-MR Ablation Catheter and Vision-MR Dispersive Electrode.

The company said that the CE mark approval of Vision-MR Ablation Catheter follows the earlier approval of its Advantage-MR EP Recorder/Stimulator System in Europe.

Imricor chairman and CEO Steve Wedan said: “We are absolutely thrilled to bring to market our products for performing cardiac catheter ablations guided by real-time MRI. Receipt of CE mark approval marks a major accomplishment for the Imricor team, as we pursue our mission to improve the lives of people worldwide by delivering devices that enable iCMR procedures.”

“With inventory located in our European warehouse and a well-established roll out plan in place, we will now move swiftly to the execution of a controlled commercial launch to ensure smooth adoption and good clinical outcomes.”

Imricor has designed Vision-MR Ablation Catheter to work under MRI guidance

The company said that it has designed the new Vision-MR Ablation Catheter to work under real-time MRI guidance.  Imricor claims to be the first company to offer cardiac ablation devices for the use in an MRI environment.

Its new ablation catheter is said to offer superior outcomes along with faster and safer treatment than conventional procedures performed using x-ray guided catheters.

Imricor will provide hospitals and clinics with capital and consumable products for interventional cardiac magnetic resonance imaging (iCMR) labs, where ablation procedures are performed using its new Vision-MR Ablation Catheter.

The company has signed agreements with numerous sites for the sale of its products.  Equipped with Advantage-MR systems, the sites are ready to start procedures, with the present CE mark approval.

Imricor marketing director Nick Twohy said: “The future of cardiac ablation therapy is in MR-guidance and this product launch is the first step towards a new standard of care. We look forward to partnering with healthcare professionals to offer a new treatment option for patients who suffer from arrhythmias.”